Blood component separation method and apparatus

ABSTRACT

An apparatus and method for collecting whole blood and then separating it into components for subsequent use or storage. A self-contained bag set is used to collect the sample, which may then be placed into a device adapted to fit into a centrifuge for separation of components. Each component is then sequentially extracted according to density, with a sensor present in the device to control the operation of valves directing the collection of each component. Each component may then be separated into its own storage container.

FIELD OF THE INVENTION

The following invention relates generally to instrumentalities andmethodologies in blood component separation. More specifically, theinstant invention is directed to a method and apparatus for collecting ablood sample and subsequently separating the collected sample intoconstituent blood components for individual storage or use.

BACKGROUND OF THE INVENTION

Blood collection is always important, particularly in times of emergency(immediate use), but whole blood may only be stored for about 30 daysbefore it is “outdated”. For long term storage, the ability to separatethe whole blood into its major components (white blood cells, platelets,red blood cells and plasma) is of paramount importance because the longterm storage condition for each component is different in terms oftemperature and storage media. The most important component separationsoccurring after collection is the separation of red blood cells (RBC),white blood cells (WBC), platelets, and plasma from one another. Withinthe WBC it is sometimes important to separate the granulocytes from thelymphocytes. After separation and extraction of particular components, afraction of the blood may be returned to the patient.

It is possible to separate the various components of whole blood eitherunder or after centrifugation, due to their differing densities. Someprior art methods, such as that in U.S. Pat. No. 4,120,448, utilize achamber connected to a centrifuge. The centrifuged blood separates inthe chamber, and a plurality of collection means are positioned atvarious locations in the chamber corresponding to the areas where eachcomponent congregates, which is density-dependent.

The following prior art reflects the state of the art of which applicantis aware and is included herewith to discharge applicant's acknowledgedduty to disclose relevant prior art. It is stipulated, however, thatnone of these references teach singly nor render obvious when consideredin any conceivable combination the nexus of the instant invention asdisclosed in greater detail hereinafter and as particularly claimed.

PATENT NO. ISSUE DATE INVENTOR 4,120,448 Oct. 17, 1978 Cullis 4,720,284Jan. 19, 1988 McCarty Des. 314,824 Feb. 19, 1991 Moon 5,674,173 Oct. 7,1997 Hlavinka et al. 5,723,050 Mar. 3, 1998 Unger et al. 5,792,038 Aug.11, 1998 Hlavinka 5,921,950 Jul. 13, 1999 Toavs et al. 6,315,706 Nov.13, 2001 Unger et al. 6,348,031 Feb. 19, 2002 Unger et al. 6,652,475Nov. 25, 2003 Sahines et al. WO95/01842 Published: Jan. 15, 1995 Unger

The prior art references listed above but not specifically describedteach other devices for blood processing and further catalog the priorart of which the applicant is aware. These references diverge even morestarkly from the reference specifically distinguished above.

SUMMARY OF THE INVENTION

The present invention comprises a bag set that may be used to collect awhole blood sample from a source. The bag set is then placed into acentrifuge for component separation. The whole blood processing bag,which contains an anticoagulant such as CPD, ACD or CPD-A, contains atleast one inlet and one outlet port connected to a plurality ofcomponent bags. Each component bag has a separate line leading from thewhole blood processing bag, and each line can be clamped, tube-sealedand separated from the whole blood processing bag once a particularcomponent bag has been filled.

In practice, the blood is collected and directed into an inlet port onthe whole blood processing bag and the input line is clamped, sealedoff, and separated from the whole blood processing bag. The whole bloodprocessing bag, which is asymmetrically shaped, hangs in a bag setholder having a complementally shaped opening that closely contacts thebag at the bottom end, and an exterior of the bag set holder is adaptedto fit in a conventional centrifuge cup or socket. The centrifuge isoperated at varying G-forces to optimally separate the components. Oncethe components are separated by density in the whole blood processingbag, a servo motor is engaged to open a metering valve on the lineleading from the processing bag to a bag that will contain the densestcomponent. This allows the densest component to fill its particularstorage bag, usually under centrifugation.

Complete collection of the first component is indicated by an opticalsensor that is present in the bag set holder device. The servo motor,directed by the sensor, automatically closes the metering valve on theline, terminating collection of that particular component. The servomotor then further engages the metering valve to allow collection of thenext component through a second output line connecting the meteringvalve and the second storage bag. The process may sequentially continueuntil all desired components are collected in separate storage bags: redblood cells, white blood cells (lymphocytes and granulocytes),platelets, and plasma. If so desired, multiple components, such as thewhite blood cells and the platelets can be directed to the same storagebag.

Once collected, each storage bag may be sealed off and separated fromthe whole blood processing bag. Any necessary preservatives or additivesmay be introduced through the collection lines before processing orstoring.

OBJECTS OF THE INVENTION

Accordingly, it is a primary object of the present invention to providea new and novel device and method for separating the components of wholeblood for subsequent storage or use.

It is a further object of the present invention to provide a device andmethod as characterized above in which separation may be accomplishedentirely by machine during a single centrifugation run without theconsiderable handling and multiple centrifugation runs typicallypracticed in a blood bank.

It is a further object of the present invention to provide a device andmethod as characterized above in which the separation apparatus isself-contained to simplify the operation.

Viewed from a first vantage point, it is an object of the presentinvention to provide a device for sequestering components from wholeblood, comprising, in combination: a bag set, said bag set including afirst bag and plural other bags; a bag set holder, whereupon the firstbag is contained within an interior portion of the bag set holder, andthe plural other bags located at an elevation lower than the holder; anda centrifuge having at least two diametrically opposed receivingsockets, at least one socket dimensioned to receive the bag set holder.

Viewed from a second vantage point, it is an object of the presentinvention to provide an apparatus for use with a conventional centrifugeand a blood processing bag set, comprising, in combination: a firstpocket having an unenclosed top portion, the first pocket dimensioned toreceive a blood processing bag; means to support the blood processingbag in the first pocket, the support means located adjacent theunenclosed top portion of the first pocket; a movable bottom portionbelow the first pocket, the movable bottom portion having an openposition and a closed position; a hinged portion located along a longaxis of the first pocket, the hinged portion opening to allow access tothe first pocket when the movable bottom portion is in the openposition; and a second pocket, wherein access to the second pocket isonly possible when the movable bottom portion is in the open position.

Viewed from a third vantage point, it is an object of the presentinvention to provide a method for separating components from wholeblood, the steps including: preparing a blood processing bag set havinga processing bag, at least one auxiliary bag, a sampling site adjacentthe processing bag, and a sampling site adjacent each auxiliary bag;introducing whole blood into the processing bag; sampling the wholeblood for later analysis; centrifuging the whole blood, whereincomponents are separated in the processing bag; directing each componentinto the at least one auxiliary bag of the blood processing bag set;removing a sample of each component for later analysis; and storing eachcomponent for later use.

Viewed from a fourth vantage point, it is an object of the presentinvention to provide a bag set, comprising, in combination: a first baghaving an inlet and an outlet; plural auxiliary bags, each auxiliary baghaving at least one port for admitting or expelling contents of theauxiliary bags; conduit means leading from the first bag to eachauxiliary bag; valve means on the conduit means, the valve meansadjustable to allow selective access between the first bag and theplural auxiliary bags.

These and other objects will be made manifest when considering thefollowing detailed specification when taken in conjunction with theappended drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the bag set holder of the present invention in openposition.

FIG. 2 shows the bag set holder of the present invention in closedposition

FIG. 3 shows the bag set of the present invention.

FIG. 4 shows the bag set in position in the bag holder in open position.

FIG. 5 shows the bag set in position in the bag holder in closedposition.

FIG. 6 shows positioning of two bag holders in a conventionalcentrifuge.

FIG. 7 shows the bag set in the bag set holder before componentseparation.

FIGS. 8A,8B,8C show the stages of harvesting components from theprocessing bag.

FIG. 9 shows the bag set in the bag set holder after componentseparation.

FIG. 10 shows the bag set after collection of a blood sample beforecomponents are separated.

FIG. 10 a depicts the same state as FIG. 10, but without theintermediate buffycoat bag.

FIG. 11 shows the bag set after the red blood cell component isseparated.

FIG. 11 a depicts the same state as FIG. 10, but without theintermediate buffycoat bag.

FIG. 12 is a flowchart of the preferred process.

FIG. 13 illustrates the separation of whole blood components ingraphical form.

FIGS. 14A,14B,14C show the operating positions of the metering valve.

FIG. 15 shows an alternative embodiment of the bag set.

FIG. 16 shows the attachment of a collection bag to the bag set.

FIG. 17 shows the operation of draining the contents of the collectionbag into the processing bag of the bag set.

FIG. 18 shows the disconnection of the connection bag and clot filterfrom the bag set.

FIG. 19 depicts the process of filling the sampling pillow with bloodfrom the processing bag.

FIG. 20 shows the disconnection of the sampling pillow and itsassociated sampling port from the bag set.

FIG. 21 depicts the addition of a sedimenting agent to the processingbag.

FIG. 22 illustrates the insertion of the bag set into the bag setholder.

FIG. 23 is a depiction of the transfer of blood components that occursunder centrifuge while the bag set is in the bag set holder.

FIG. 24 shows the disconnection of the red blood cell bag from the bagset.

FIG. 25 illustrates the manner in which the contents of the freezing bagare mixed.

FIG. 26 depicts the process of filling the sampling pigtail with thecontents of the freezing bag.

FIG. 27 shows the disconnection of the sampling pigtail and itsassociated sampling port from the bag set.

FIG. 28 depicts the addition of DMSO into the freezer bag and itssubsequent mixing.

FIG. 29 illustrates the manner in which residual DMSO and air is drawnout of the system.

FIG. 30 shows the disconnection of the freezing bag from the bag set.

FIG. 31 illustrates the manner in which samples from the freezing bagportion are created for preservation.

FIG. 32 shows the extraction of processing bag material and the smallamount of freezing bag material left in the tubing from FIG. 31 forsubsequent analysis.

FIG. 33 shows the disconnection of the DMSO inlet line and itsassociated junctions from the processing bag.

FIG. 34 illustrates the manner in which samples are taken from theprocessing bag for subsequent analysis.

FIG. 35 is a schematic of the servo motor and valve system connections.

DESCRIPTION OF PREFERRED EMBODIMENTS

Considering the drawings, wherein like reference numerals denote likeparts throughout the various drawing figures, reference numeral 10 asshown in FIG. 3 is directed to the bag set according to the presentinvention.

In its essence, the bag set 10 includes a whole blood processing bag 2,a red blood cell (RBC) bag 4 having a hanger 16, and a freezing bag 6for the collection and storage of white blood cells. The processing bag2 is supplied through an inlet line 12, preferably through a phlebotomyneedle 8 (FIG. 10). The processing bag 2 has an asymmetric shapeincluding a top edge 11 a, a short side edge 11 b, a long side edge 11c, and a sloped bottom edge 11 d between the side edges such that thebottom portion tapers to an asymmetric point 14, which leads to anoutlet 26. The outlet 26 directs output from the processing bag 2 into athree-way metering valve 20. The operating positions of the meteringvalve 20 are shown in FIGS. 14A–14C. Two supply lines 24 a,24 b leadfrom the metering valve 20 to the RBC bag 4 and the freezing bag 6,respectively. The supply lines 24 a,24 b and the inlet line 12 may eachbe heat sealed and separated from the bag set 10. All lines are equippedwith line clamps 22 that may be closed to prevent fluid passage whendesired. If other components are to be separated, the bag set 10 mayinclude additional bags with a corresponding adjustment to the meteringvalve 20 to accommodate the additional bags.

Various supply lines may also be present in the bag set 10. For example,the freezing bag supply line 24 b may have an inlet 16 for theintroduction of cryoprotectant into the system. Such inlets may beequipped with filters 30 (see, e.g., FIG. 10), preferably 0.2μ filters,to, inter alia, prevent contamination from pathogens in the outside airand to allow venting of air from the freezing bag and tubing. Anintermediate buffycoat bag 40 (FIG. 10) may be present on the freezingbag supply line 24 b. The buffycoat bag 40 collects a separate buffycoatfraction, which includes platelets and white cells and includes somesmall volume of plasma or red blood cells. FIGS. 10 a and 11 a show thebag set without the intermediate buffycoat bag 40.

Initially, the processing bag 2 is filled with an anticoagulant, such asCPD (citrate, phosphate, and dextrose). The metering valve 20 begins inthe closed position (FIG. 9A). All clamps 22 are closed with theexception of the clamp 22 on the inlet line 12. Blood, preferably whole,placental, or umbilical cord blood, is obtained from a source throughthe phlebotomy needle 8 or other appropriate inlet, which feeds into theprocessing bag 2 through the inlet line 12. The inlet line 12 is thenclamped, heat sealed, and separated from the bag set 10. HES may beintroduced into the RBC bag 4 through an optional inlet either before orafter blood collection.

At this point, the bag set 10 is placed in a bag holder 50, shown inFIGS. 1,2. The bag holder 50 is somewhat cylindrical, having asubstantially elliptical shape, having two rounded ends connected bysubstantially straight sides. The main compartment 70 has an elongatedoval shape dimensioned to receive the processing bag 2. The maincompartment 70 is accessed by sliding down a bottom portion 162 of thebag holder 50 (along arrow Z), then opening a cover 72 about a hinge 71(along arrow X) present at one of the rounded ends of the bag holder 50.The processing bag 2 is oriented in the bag holder 50 such that thehinged cover 72 closes over the edge 11 c coinciding with the point 14leading to the metering valve 20. The metering valve 20 is received inan orifice 74 a located on the major portion of the bag holder 50. Acomplemental orifice 74 b, located on the hinged cover 72, receives theprotruding end of the metering valve 20. The hinged cover 72 will onlyclose when the bottom portion 162 is in the closed position. When thebottom portion is closed, a notch 164 in the bottom portion 162registers with a retaining tab 166 present on the main body of the bagholder 50.

Referring to FIG. 1, the bag holder 50 includes a bag hanger 76 havinghooks 60 that engage the loops 28 on the processing bag 2, maintainingthe bag in position during the centrifuging process. The maincompartment 70 of the bag holder 50 is shaped to receive the processingbag 2, having a sidewall 156 that is complemental to the asymmetricshape of the processing bag 2, which terminates in an outport 160dimensioned to receive the asymmetric point 14 and the outlet 26 of theprocessing bag 2. The sidewalls 156 cradle the processing bag 2 looselyaround the middle and more tightly at the bottom (near the outlet 26).Closer tolerance near the bottom of bag 2 is desired to minimizedisturbing the contents of the bag after sedimentation. Thus, the top ofcompartment 70 mirrors the exterior elliptical shape but tapers down tothe outport 160 while maintaining bag edges 11 b,11 c,11 d in supportingrelationship.

A notch 78 is present along one of the substantially straight sides ofthe bag holder 50. The notch 78 receives the hanger 16 on the RBC bag 4.The RBC bag 4 hangs along the outside of the bag holder 50 in a curvedrecess 80 leading to a lower support shelf 83 via transition 81. Thefreezing bag 6 is cradled in a receptacle 82 located beneath the maincompartment 70 of the bag holder 50, accessed by sliding the bottomportion 162 down to open along arrow Z. FIGS. 4 and 5 show the entirebag set 10 loaded in the bag set holder 50 before component separationoccurs.

The metering valve 20 is connected to a motor driver 56 in the bagholder 50. The servo motor 56 is connected to a software-controlledcontrol chip module 57 powered by a rechargeable battery B. A port P isprovided to utilize a battery charger C (FIG. 35). The servo motor 56controls the operation of the metering valve 20 while the bag set 10 ismounted in the bag holder 50. One or more optical sensors 58 trigger theproper time for the servo motor 56 to close the metering valve 20 aftereach fraction is harvested. The sensor may be present at the positionshown in FIG. 1 or lower, closer to the outport 160 adjacent theasymmetric point 14 of the processing bag 2.

The bag holder 50, when closed, is adapted to fit into a centrifuge cup66 dimensioned to reside within a conventional centrifuge 100.Preferably, at least two bag set holders are placed in diametricallyopposed centrifuge cups 66, as shown in FIG. 6, for balance. A bag set10 in the centrifuge cup 66 may be subjected to more than one G-force inorder to achieve the optimum stratification of components (FIGS. 8A–8C).The servo motor 56 then operates the metering valve 20 to open and allowaccess to supply line 24 a for the harvest of red blood cells, at anoptimum G-force, into bag 4. The servo motor 56 closes the meteringvalve 20 when the optical sensor 58 indicates that the red blood cellsare harvested (FIGS. 8A,8B). The optical sensor 56 senses the boundarybetween the white cell fraction and the plasma fraction.

The next fraction, which includes white cells and/or platelets, is thenharvested from the processing bag 2; the servo motor 56 opens themetering valve 20 to allow access to supply line 24 b (FIG. 9C) leadingto bag 6 for the next harvest. As shown in FIG. 9, during the harvest(WBC) into the freezing bag 6, air in the supply line adds to airalready in the freezing bag 6, producing an air bubble 70, which isuseful to assist the proper mixing of the WBC and/or platelets with thecryoprotectant. The servo motor 56 then closes the metering valve 20, asshown in FIG. 9A, and the centrifuge 100 is allowed to stop. FIG. 9shows the bag set 10 in the bag set holder 50 after component separationhas taken place.

The buffycoat bag 40, if present, preferably has a 25 mL capacity. 20 MLof buffycoat is introduced into the buffycoat bag 40, and 5 mL of DMSOsolution is subsequently introduced. The buffycoat bag is placed betweentwo cold strata and kneading of the buffycoat bag 40 takes place.

The bag holder 50 is removed from the centrifuge cup 66 and opened, andthe bag set 10 is removed, with the servo motor 56 disconnected from themetering valve 20. Each supply line 24 a,24 b is clamped, heat sealed,and removed from the processing bag 2. Any additional bags may besimilarly removed.

After the supply line 24 b connected to the freezing bag 6 isdisconnected, a cryoprotectant may be introduced into the component inthe freezing bag 6 through an inlet. The air bubble 70 in the freezingbag 6 allows the cryoprotectant to be thoroughly mixed with thecollected component. After mixing, the air bubble 70 is expelled,perhaps through a filter-protected cryoprotectant inlet 16 (FIG. 10).The component is then prepared for storage by heat-sealing the tubingand removing the bag 6 downstream of the cryoprotectant inlet 16.

Preferably, each line (the inlet line 12 and the supply lines 24 a,24 b)is oriented to allow access to a sampling site (e.g., site 18) near thecollection or storage bags. Thus, a sample of the blood or fluid in theline may be taken without disturbing the bulk of the collectedcomponent.

FIG. 13 depicts the separation of whole blood components as a functionof time. Under centrifugation, each fraction stratifies in theprocessing bag 2 as a function of its density. The overlapping areas 175indicate the area in the separation along each strata line in theprocessing bag 2. As centrifugation continues, the boundary of eachfraction becomes more clearly defined; thus, the area 175 decreases andeach fraction is more completely harvested. Thus, the centrifugationstrategy combines separation by density, the time involved forstratification, centrifuge force, and boundary layer clarity. Decisionson harvesting will vary based on these tradeoffs as a function of theconstituent of greatest value and its desired purity.

Preferably, the stratification centrifugation occurs at an excess of1000 Gs, preferably 1400 Gs, for approximately 20 minutes. The transfercentrifugation step occurs at less than 100 Gs, preferably 78 Gs, andstops subject to output from the optical sensor 58.

It is appreciated that while the instant invention is preferably used inthe separation of blood components, the separation techniques andapparatus are suitable for separation of other fluids. The softwareprogrammed into the control chip module may cause the servo motor toopen and close the valve many times, thereby throttling the valve duringstrata delivery. Also by varying time increments during a harvestprocedure, precise cut-offs between the cell components can be achievedin order to reduce the mixing between cell types that may occur as aresult of the “toroidal” (Coriolis) effect during removal of the bloodcomponent from processing bag 2 and may be modified for the separationof other fluids or to compensate for various hardware conditions, suchas uneven centrifuge loading.

Yet another embodiment of the bag set 210 is shown in FIG. 15. In itsessence, the bag set 210 includes a whole blood processing bag 202, ared blood cell (RBC) bag 204, and a freezing bag 206. The processing bag202 is supplied through an inlet line 212 that terminates in a spike208. The processing bag 202 has an asymmetric shape including a top edge211 a, a short side edge 211 b, a long side edge 211 c, and a slopedbottom edge 211 d between the side edges such that the bottom portiontapers to an asymmetric point 214, which leads to an outlet 226. Theoutlet 226 directs output from the processing bag 202 into a stopcockvalve 220. Two supply lines 224 a,224 b lead from the stopcock valve 220to the RBC bag 204 and the freezing bag 206, respectively. The supplylines 224 a,224 b and the inlet line 212 may each be heat sealed andseparated from the bag set 210. All lines are equipped with line clamps222 that may be closed to prevent fluid passage when desired. If othercomponents are to be separated, the bag set 210 may include additionalbags with a corresponding adjustment to the stopcock valve 220 toaccommodate the additional bags.

Initially, the blood of interest is collected in a collection bag 200 orsimilar container. The spike 208 is inserted into the collection bag200, and the blood is drained from the collection bag 200 into theprocessing bag 202 through the inlet line 212 (FIGS. 16,17). The inletline 212 preferably has a clot filter 230, through which the bloodpasses before it reaches the processing bag 202. After the blood istransferred, the inlet line 212 is heat sealed and the collection bag200 and clot filter 230 are removed (FIG. 18).

The inlet line 212 also preferably has a sampling port 232, a samplingpillow 234, and an access port 236 (FIG. 19). After the collection bag200 and clot filter 230 are moved from the inlet line 212, the samplingpillow 234 is squeezed and released to fill the sampling pillow withblood. The inlet line 212 is then heat sealed and the sampling pillow234 is removed, along with the sampling port 232 (FIG. 20). The blood inthe sampling pillow 234 may then be accessed through the sampling port232 for separate assay.

A sedimenting agent, such as hydroxyethyl starch (HES) is added to theprocessing bag 202 through the access port 236 on the inlet line 212using syringe means 236 a or similar delivery means, and the processingbag 202 is manipulated to thoroughly mix the agent with the blood (FIG.21). The bag set 210 is then placed into the bag holder 50 and used witha centrifuge, as detailed hereinabove, to separate the cells therewithin(FIG. 22). The separated red blood cells are transferred into the RBCbag 204 and the buffy coat is transferred to the freezing bag 206 duringthis operation. The bag set 210 is the removed from the bag holder 50(FIG. 23). Supply line 224 a is then heat sealed and the RBC bag 204 isremoved (FIG. 24). The contents of the RBC bag are accessed through asample port 238.

Referring to FIG. 25, supply line 224 b is preferentially equipped witha first junction 260 connecting an auxiliary inlet line 240 terminatingin an auxiliary port 242. A second junction 262 is present on theauxiliary inlet line 240 itself to connect a branch line 244 thatterminates in a bulb 246. The branch line 244 also contains a samplingpigtail 248 and a sampling port 250. After removal of the RBC bag 204,the bulb 246 on the branch line 244 is squeezed to direct any residualplasma remaining in the supply line 224 b into the freezing bag 206.Clamp 222 on branch line 244 is then closed. The contents of thefreezing bag 206 are then mixed, preferably by holding the freezing bag206 at a 45° angle and slowly squeezing the small compartment 206 a ofthe freezer bag 206 a total of ten times at one squeeze per second.

The clamp 222 on the branch line 244 is then opened, and the bulb 246 issqueezed and released to fill the sampling pigtail 248 with the contentsof the freezer bag 206 (FIG. 26). The branch line 244 is heat sealed andremoved from the bag set 210 (FIG. 27). The contents of the samplingpigtail 248 are accessed through the sampling port 250 for separateassay.

The freezing bag 206 is placed on its side and sandwiched between twoice packs 252 (FIG. 28). DMSO is introduced into the freezing bag 206through the auxiliary port 242 on the auxiliary inlet line 240. Anorbital mixer 254 is used with the sandwiched freezer bag 206 tothoroughly mix the contents of the freezer bag 206. The sandwichedfreezer bag 206 is then placed in stationary holder 256 (FIG. 29). Asyringe 258 is inserted into the auxiliary inlet 242 and used to drawout any residual DMSO and trapped air in the supply line 224 b and theauxiliary inlet line 240. The buffy coat/DMSO from the freezing bag 206is drawn out by the syringe 258 until it reaches the second junction 262from the supply line 224 b. The freezing bag 206 is then removed fromthe bag set 210 by heat sealing the supply line 224 b (FIG. 30).

A portion of the supply line 224 b after the first junction 260 remainsattached to the freezing bag 206. This portion of the supply line 224 bis heat sealed to form three separate samples 275 a,275 b,275 c (stillconnected to the freezing bag 206), and the area separating the smallcompartment 206 a of the freezer bag 206 is heat sealed to separate itfrom the rest of the freezer bag 206 (FIG. 31). The final product isthen frozen for storage.

The stopcock valve 220 is turned to allow plasma in the processing bag202 to contact the buffy coat in the supply line 224 b near the firstand second junctions 260,262 (FIG. 32). A sample of the plasma dilutedbuffy coat is drawn into the syringe 258 for bacterial sampling, and thesyringe 258 is removed from the auxiliary port 242. The supply line 224b containing the auxiliary line 240 and the first and second junctions260,262 is then disconnected from the processing bag 202 and isdiscarded (FIG. 33). Samples of the plasma in the processing bag 202 maybe removed by using the access port 236 (FIG. 34).

Moreover, having thus described the invention, it should be apparentthat numerous structural modifications and adaptations may be resortedto without departing from the scope and fair meaning of the instantinvention as set forth hereinabove and as described hereinbelow by theclaims.

1. An apparatus for use with a conventional centrifuge and a bloodprocessing bag set, comprising, in combination: a first pocket having anunenclosed top portion, said first pocket dimensioned to receive a bloodprocessing bag; means to support the blood processing bag in said firstpocket, said support means located adjacent said unenclosed top portionof said first pocket; a movable bottom portion below said first pocket,said movable bottom portion having an open position and a closedposition; a hinged portion located along a long axis of said firstpocket, said hinged portion opening to allow access to said first pocketwhen said movable bottom portion is in said open position; and a secondpocket, wherein access to said second pocket is only possible when saidmovable bottom portion is in said open position.
 2. The apparatusaccording to claim 1 wherein said first pocket further comprises atapered bottom portion to hold the blood processing bag.
 3. Theapparatus according to claim 2 further comprising means to hold at leastone auxiliary bag of a blood processing bag set.